Onyx says combination therapies are Nexavar's future

By Jennifer Lanning Drey

Eugene, Ore., June 9 - Onyx Pharmaceuticals, Inc. plans to combine Nexavar (sorafenib) with other active drugs and treatments, according to Dr. Hank Fuchs, executive vice president and chief medical officer for Onyx.

"The future of Onyx is going to be in combination studies in which active drugs are combined one with the other," said Fuchs during Onyx's analyst review held Thursday.

The analyst meeting was a follow up to Onyx's presentation at the Annual Meeting of the American Society of Clinical Oncology at which it gave an update on results of a phase 3 clinical trial of Nexavar in patients with advanced renal cell carcinoma. The results did not reach the pre-specified result required to stop the overall survival analysis early, as the company had hoped, according to a news release.

But the company said the data did suggest a favorable survival trend for patients who received Nexavar.

The updated data showed a continued improvement in overall survival of 19.3 months for Nexavar patients versus 15.9 months for placebo patients, despite the fact that 48% of placebo patients crossed over to Nexavar, according to a company news release.

"We see encouraging evidence despite almost 50% cross over," Fuchs said Thursday.

Nexavar is approved for patients with renal cell carcinoma, or kidney cancer, and is being tested in patients with malignant melanoma, liver cancer and lung cancer.

Dr. Janice Dutcher, a professor of medicine at New York Medical College, said clinicians are anxiously awaiting combination trials of drugs that focus on renal cell carcinoma.

"Renal cell cancer is a rapidly moving target," she said at Thursday's analyst day.

In particular, clinicians are seeking combinations that could provide durable stabilization measured in years and decreased toxicity for drugs given on a chronic basis, she said.

Dutcher also said that with an abundance of similar drugs that use antiangiogenesis to treat renal cell carcinoma, clinicians are looking at criteria such as whether they can prescribe a drug serially and get serial results, as well as factors such as cross-resistance, mechanism of resistance and preferred sequence, she said.

Combinations of Nexavar with antiangiogenesis would be a likely target for Onyx to pursue in the future, Fuchs added.

Plans combination trial for melanoma

Onyx also reported on Thursday that it has had encouraging preliminary data from small studies of Nexavar in combination with carboplatin/pacitaxel for treatment of malignant melanoma and will launch a phase 3 randomized clinical trial in patients with advanced metastatic melanoma, he said.

The study will build on previous data developed in a two-site single arm study of 100 patients that recorded median progression-free survival of 8.8 months.

"If this trial is as successful as we expect it to be, we believe this will support registration of the product," said Fuchs.

Onyx is also testing Nexavar in combination studies with temozolomide in patients with malignant melanoma, he said.

In addition, Onyx has completed enrollment in phase 3 trials of Nexovar in patients with hepatocellular carcinom, or liver cancer.

"I think Nexavar is going to make a big difference in the way cancer is treated," said Fuchs.

Emeryville, Calif.-based Onyx is engaged in the development of novel cancer therapies that target the molecular basis of cancer.

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